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alogliptin and metformin

What is the most important information I should know about alogliptin and metformin?

You should not use this medicine if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

What is alogliptin and metformin?

Alogliptin and metformin are oral diabetes medicines that help control blood sugar levels.

Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Alogliptin works by regulating the levels of insulin your body produces after eating.

Alogliptin and metformin is a combination medicine used with diet and exercise to improve blood sugar control in adults with type 2 diabetes.

This medication is not for treating type 1 diabetes.

Alogliptin and metformin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking alogliptin and metformin?

You should not use this medicine if you are allergic to alogliptin or metformin, or if you have:

severe kidney disease; or

diabetic ketoacidosis (call your doctor for treatment with insulin).

Some people taking alogliptin and metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.

To make sure this medicine is safe for you, tell your doctor if you have:

kidney disease;

heart disease;

liver disease;

a history of pancreatitis;

gallstones;

a history of alcoholism; or

if you are over 80 years old and have not recently had your kidney function checked.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking alogliptin and metformin. Be sure your caregivers know ahead of time that you are using this medicine.

Follow your doctor's instructions about using this medicine if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

This medicine may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

It is not known whether alogliptin and metformin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 18 years old.

How should I take alogliptin and metformin?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Alogliptin and metformin is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Your doctor may have you take extra vitamin B12 while you are taking alogliptin and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking alogliptin and metformin?

What are the possible side effects of alogliptin and metformin?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Stop taking this medicine and get emergency medical help if you have even mild symptoms such as:

severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alogliptin and metformin?

Other drugs may increase or decrease the effects of alogliptin and metformin on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about alogliptin and metformin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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